Engineering Manager, R&D

Engineering Manager 100% on-site in Westlake Village, CA Caldera Medical’s Mission: To Improve the Quality of Life for Women! Message from the Hiring Manager Caldera Medical is scaling its R&D organization to accelerate new product development, sustain existing product lines, and strengthen engineering execution across the portfolio. This Engineering Manager will lead a team of design, development, and sustaining engineers to deliver on the product roadmap while ensuring compliance with FDA and international regulatory requirements. The role is critical to maintaining Caldera's competitive advantage in pelvic floor therapies and supporting expansion into adjacent women's health categories. Duties and Responsibilities Lead and manage a team of R&D engineers through all phases of product development from concept through commercialization Own the engineering project portfolio: set priorities, allocate resources, manage timelines, and ensure deliverables meet quality and regulatory standards Drive design control processes in accordance with FDA 21 CFR 820, ISO 13485, and EU MDR requirements Partner cross-functionally with Quality, Regulatory, Operations, and Commercial teams to ensure seamless product launches Develop and mentor engineering talent; build a high-performance team culture aligned with Caldera's mission and values Manage engineering budgets, capital expenditures, and vendor/contractor relationships Support sustaining engineering activities including CAPAs, design changes, and supplier qualifications Present project status, risks, and resource needs to executive leadership on a regular cadence 20% Travel expected Required Knowledge, Skills, and Abilities Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline (Master's preferred) 8+ years of progressive engineering experience in the medical device industry, with at least 3 years in a people management role Direct experience with Class II or Class III medical devices through the full product development lifecycle (concept to market) Working knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and EU MDR Experience managing engineering budgets and vendor relationships Strong proficiency in CAD (SolidWorks preferred), PLM systems, and engineering documentation practices Desired Knowledge, Skills, and Abilities Leadership & People Development: Proven ability to build, motivate, and develop engineering teams in a fast-paced, resource-constrained environment Technical Depth in Medical Devices: Strong working knowledge of design controls, risk management (ISO 14971), biocompatibility, and manufacturing process validation Project & Portfolio Management: Demonstrated skill managing multiple concurrent development programs with competing priorities Cross Functional Collaboration: Track record of effective partnership with Quality, Regulatory, Operations, and Commercial stakeholders Problem Solving & Decision Making: Ability to diagnose root causes, make sound technical decisions under uncertainty, and drive issues to closure Communication: Clear, concise communicator who can translate complex engineering topics for executive and non-technical audiences Competitive Compensation, Comprehensive Benefits, and More Medical and Dental Benefits Vision Coverage 401(k) with 4% matching contributions after 90 days of employment Basic Life and AD&D Unlimited Vacation Policy 6 Weeks Paid Maternity Leave 10 paid holidays Being surrounded by amazing people! Our Culture – Where Career and Passion come together! A Culture of family and team… not a corporate goliath where you’re just another number. All employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California. The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first. Our goal is to treat 1 million women suffering from incontinence by 2027! Who is Caldera Medical? Caldera Medical is dedicated to improving the quality of life for women through innovative surgical solutions for stress urinary incontinence, pelvic organ prolapse, polyps, and fibroids. Our products are trusted by surgeons worldwide, and our commitment extends beyond medical advancements. We foster strong partnerships with surgeons and lead the largest humanitarian program in women’s health, aiming to provide treatment to one million underserved women by 2027. Guided by integrity, we prioritize patients, customers, employees, and the community over profit. As the fastest-growing women’s health company, we remain committed to expanding education and access to life-changing care for women everywhere. Equal Opportunity Employer Statement Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law. #J-18808-Ljbffr